Clinical Trials

Multiple clinical trials span Phase 1 through Phase 3, as well as unspecified phase designs, to evaluate sunvozertinib in locally advanced, metastatic, and resectable non-small cell lung cancer harboring EGFR exon 20 insertion mutations. Sponsored by pharmaceutical entities like Dizal Pharmaceuticals and academic medical centers such as Henan Cancer Hospital and Hunan Province Tumor Hospital, these investigations evaluate safety, efficacy, and head-to-head performance against standard chemotherapy. Recruitment statuses across the portfolio range from not yet recruiting and active, not recruiting, to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07274761 ACTIVE_NOT_RECRUITING
Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer; Non Small Cell Lung Cancer
Shanghai Pulmonary Hospital, Shanghai, China
 2024-10-17 PHASE2
NCT07182682 RECRUITING
Non-Small Cell Lung Cancer
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
 2025-12-01 PHASE3
NCT07079475 RECRUITING
Non-Small Cell Lung Cancer
Dizal Pharmaceuticals
 2025-07-30 PHASE1; PHASE2
NCT06195189 RECRUITING
Non Small Cell Lung Cancer
Sichuan University
 2024-02-29 PHASE1; PHASE2
NCT06563999 RECRUITING
Lung Cancer Stage III; Mutation
Sun Yat-sen University
 2024-11-01 PHASE2
NCT06905197 RECRUITING
Non Small Cell Lung Cancer
Dizal Pharmaceuticals
 2025-05-13 PHASE1
NCT07117890 RECRUITING
Non Small Cell Lung Cancer
Fudan University
 2025-02-07 PHASE2
NCT06864624 RECRUITING
NSCLC
Tang-Du Hospital
 2025-02-18 PHASE2
NCT05668988 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Dizal Pharmaceuticals
 2022-12-13 PHASE3
NCT06182761 NOT_YET_RECRUITING
NSCLC
Shanghai Zhongshan Hospital
 2024-01 PHASE2
NCT06355609 RECRUITING
Non-small Cell Lung Cancer
Hunan Province Tumor Hospital
 2024-07-01 PHASE2
NCT06348927 RECRUITING
Non-Small Cell Lung Cancer
Hunan Province Tumor Hospital
 2024-07-01 PHASE2
NCT03974022 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Dizal Pharmaceuticals
 2019-07-09 PHASE1; PHASE2
NCT05712902 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Dizal Pharmaceuticals
 2021-07-19 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the Sunvozertinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sunvozertinib acts as a potent and selective inhibitor that binds to ErbB family tyrosine kinases, specifically targeting mutant forms of epidermal growth factor receptor and HER2 to block downstream oncogenic signal transduction and suppress cancer cell proliferation. By inhibiting signaling driven by EGFR mutations such as exon 20 insertions, this targeted action halts cellular growth and tumor progression, providing a clear rationale for its evaluation in non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.